Drug Safety Research Unit Japan (DSRU Japan) is a nonprofitable organization (NPO) established as a corporate body registered to the Tokyo Metropolitan Government in 2001.
DSRU Japan worked with a close relationship to former Department of Pharmacoepidemiology, University of Tokyo which was permanently closed in 2014. The current director of DSRU Japan is Dr. Kiyoshi Kubota, MD PhD FISPE, a former chair of Department of Pharmacoepidemiology, University of Tokyo.
DSRU Japan, originally set up to support Prescription-Event Monitoring in Japan (J-PEM), has widened the mission concept after its establishment.
DSRU Japan is now dedicated to promoting better Pharmacovigilance and Pharmacoepidemiology in Japan.
Its current activities embrace scientific research, therapeutic risk management and education for pharmacoepidemiology in Japan.
DSRU Japan worked as the executive office for two pilot studies of
Prescription-Event Monitoring in Japan (J-PEM).
J-PEM has been however suspended since 2004
(See scientific publications 1-6).
B. Case-control study:
DSRU Japan has worked as a study office of a case-control study on
the association between NSAIDs and upper gastrointestinal bleeding
conducted between 2002 and 2005.
(See scientific publication 7).
C. Research on the background incidence of possible adverse drug reaction:
DSRU Japan has worked as a study office of a retrospective cohort study on
the background incidence of interstitial lung disease (ILD) in patients with
ILD is known as an adverse reaction to a wide range of anti-neoplastic drugs and
other agents occurring in Japan at a rate much higher than that in
other countries (including other Asian countries).
The research was conducted to know the background incidence of ILD in
Japanese patients with malignant mesothelioma to evaluate possible occurrence of
ILD associated with the new antineoplastic agents for treatment of
(See scientific publications 8,9).
D. Japan Statin Study (JSS):
DSRU Japan has been working as a study office of the study called as
Japan Statin Study (JSS) conducted as a joint research by
Japanese Society for Pharmacoepidemiology (JSPE) and
Japanese Society of Hospital Pharmacists (JSHP).
The study is to compare the safety profiles of 6 statins available in Japan.
The study was initiated in 2008
(See scientific publication 10).
E. Therapeutic Risk Management:
DSRU Japan has been working as an executive office of
the Safety Management system for Unapproved Drugs (SMUD) by
the contract with Ministry of Health, Labour and Welfare (MHLW).
Though the system may be used for safety management of
unapproved drugs in general in the future, it is currently used to
monitor thalidomide imported by physicians.
Thalidomide approved in 2008 has been used strictly for treatment of
patients with malignant myeloma in Japan and thalidomide is still imported by physicians.
SMUD requires physicians to register initials and date of birth, gender, diagnosis of
patients for whom thalidomide will be imported.
For each registered patient, the executive office sends a brochure with
information needed to secure safe use of thalidomide.
Doctor is also requested to report serious adverse events using the
(see scientific publication 11).
F. Support for Clinical Researches:
DSRU Japan has supported 3 clinical researches mainly regarding handling of
safety information in the study
(see reference 12).
G. Disproportionality measures from Japanese Spontaneous Reports for signal detection:
Since 2003, DSRU Japan has provided lists of disproportionality measures
(PRR, ROR, GPS and BCPNN) obtained from Japanese spontaneous reports accessible through
the Internet to members of NPO DSRU Japan.
In the first couple of years, the information was provided as prints.
Since 2008, the information has been provided as CD or DVD
(see scientific publications 13,14).
H. Support for database study:
In 2011, the MHLW has started the provision of health care claims data (Japanese National Database, JNDB) on a trial basis.
DSRU Japan supported the database study by former Department of Pharmacoepidemiology using JNDB conducted between 2011 and 2013 for various aspects such as developing codes for security,
establishment of secure computer environment, etc.
DSRU Japan is also involved in the database study using a commercial database in collaboration with researchers in Special Interest Group (SIG) called as Asian Pharmacoepidemiology Network (AsPEN) of International Society of Pharmacoepidmiology (ISPE).
I. Support for education and meetings of pharmacoepidemiology:
DSRU Japan has been supporting 6-month course of pharmacoepidemiology seminar
held by Union of Japanese Scientists and Engineers conducted every year since 2006.
DSRU Japan worked as an executive office for the 2nd Asian Conference on
Pharmacoepidemiology (ACPE2) in 2007 as well as in the 5th Asian Conference on
Pharmacoepidemiology (ACPE5) in 2010.
In 2010, DSRU Japan has worked as an executive office for three 1-day tutorials
held by JSPE as well as for a 2-day open workshop for database research held by
Department of Pharmacoepidemiology of University of Tokyo.
J. Consultation for pharmacoepidemiology studies:
DSRU Japan has provided opportunities of consultation for those in charge of
designing/conducting post-marketing studies in drug companies in Japan.
All enquiries should be directed in the first instance to:
Dr. Tsugumichi Sato, executive director,
NPO Drug Safety Research Unit Japan
surface mail: 1-2-13-4F Yushima, Bunkyo-ku, Tokyo 113-0034, JAPAN
1. Kubota K.
A Design for Prescription-Event Monitoring in Japan (J-PEM).
Pharmacoepidemiol Drug Saf. 1999; 8(6): 447-456,
2. Yokotsuka M, Aoyama M, Kubota K.
The Use of a Medical Dictionary for Regulatory Activities Terminology (MedDRA)
in Prescription-Event Monitoring in Japan(J-PEM).
Int J Med Inform. 2000; 57: 139-153,
3. Kubota K, Kawabe E, Hinotsu S, Hamada C, Ohashi Y, Kurokawa K.
Pilot Study of Prescription-Event Monitoring in Japan (J-PEM) Comparing Troglitazone with Alternative Oral Hypoglycaemics.
Eur J Clin Pharmacol. 2001; 56: 831-838,
4. Tanaka K, Morita Y, Kawabe E, Kubota K.
Drug Use Investigation (DUI) and Prescription-Event Monitoring in Japan (J-PEM).
Pharmacoepidemiol Drug Saf. 2001; 10(7): 653-658,
5. Kubota K,
Prescription-Event Monitoring in Japan (J-PEM).
Drug Saf. 2002; 25(6): 441-444,
6. Samizo K, Kawabe E, Hinotsu S, Sato T, Kageyama S, Hamada C, Ohashi Y, Kubota K.
Comparison of losartan with ACE inhibitors and dihydropyridine calcium channel angtagonists.
A pilot study of Prescription-Event Monitoring in Japan.
Drug Saf. 2002; 25(11): 811-821,
B. Case-control study
7. Sakamoto C, Sugano K, Ota S, Sakaki N, Takahashi S, Yoshida Y, Tsukui T,
Osawa H, Sakurai Y, Yoshino J, Mizokami Y, Mine T, Arakawa T, Kuwayama H,
Saigenji K, Yakabi K, Chiba T, Shimosegawa T, Sheehan JE, Perez-Gutthann S,
Yamaguchi T, Kaufman DW, Sato T, Kubota K, Terano A.
Case-control study on the association of upper gastrointestinal bleeding
and nonsteroidal anti-inflammatory drugs in Japan.
Eur J Clin Pharmacol. 2006; 62(9): 765-772,
C. Research on the background incidence of possible adverse drug reaction
8. Nojiri S, Gemba K, Aoe K, Kato K, Yamaguchi T, Sato T, Kubota K, Kishimoto T.
Survival and prognostic factors in malignant pleural mesothelioma:
a retrospective study of 314 patients in the west part of Japan.
Jpn J Clin Oncol. 2011; 41(1): 32-39.
9. Nojiri S, Gemba K, Aoe K, Kato K, Yamaguchi T, Sato T, Kubota K, Kishimoto T.
Incidence of interstitial lung disease in patients with mesothelioma in the west part of Japan.
Pharmacoepidemiol Drug Saf. 2011; 20(6): 643-652,
D. Japan Statin Study (JSS)
10. Kageyama S, Kitamura M, Kokan A, Kubota K, Matsui K, Ooba N, Orii T,
Sato T, Shimodozono Y, Uehara H, Yagame M, Yaju Y, Yamaguchi T.
Japan Statin Study (JSS), a prospective case-cohort study
for monitoring multiple adverse events:
rationale, design and characteristics of study subjects.
Pharmacoepidemiol Drug Saf. 2010; 19: S169,
11. N Ooba, T Sato, A Wakana, T Orii, M Kitamura, A Kokan, H Kurata,
Y Shimodozono, K Matsui, H Yoshida, T Yamaguchi, S Kageyama, K Kubota.
A Prospective Stratified Case-Cohort Study on Statins and Multiple Adverse Events in Japan.
PLOS ONE 9(5): e96919, http://dx.doi.org/10.1371/journal.pone.0096919
E. Therapeutic Risk Management
12. Ooba N, Sato T, Watanabe H, Kubota K.
Resolving a Double Standard for Risk Management of Thalidomide:
An Evaluation of Two Different Risk Management Programmes in Japan.
Drug Saf. 2010; 33(1): 35-45,
F. Support for Clinical Researches
13. Ando K, Ohtsu H, Arakawa Y, Kubota K, Yamaguchi T, Nagase M, Yamada A, Fujita T.
Rationale and design of the Eplerenone combination Versus conventional Agents
to Lower blood pressure on Urinary Antialbuminuric Treatment Effect (EVALUATE) trial:
a double-blinded randomized placebo-controlled trial to evaluate
the antialbuminuric effects of an aldosterone blocker in hypertensive patients with albuminuria.
Hypertens Res. 2010; 33(6): 616-621,
G. Disproportionality measures for signal detection from Japanese Spontaneous Reports
14. Ooba N, Kubota K.
Selected control events and reporting odds ratio in signal detection methodology.
Pharmacoepidemiol Drug Saf. 2010; 19(11): 1159-1165,
15. Kamijima Y, Kubota K.
Potential roles of standardized MedDRA Queries in capturing patterns of
adverse drug reactions and reporting; a exploratory study in Japanese data.
ACPE Beijing 2011.
H. Database studies in Japan
16. Ooba N, Setoguchi S, Ando T, Sato T, Yamaguchi T, Mochizuki M, Kubota K.
Climas-based definition of death in Japanese claims database: validity and implcations.
PLOS ONE 2013; 8(5): e66116, http://dx.doi.org/10.1371/journal.pone.0066116
17. Kubota K, Kamijima Y, Sato T, Ooba N, Koide D, Iizuka H, Nakagawa H.
Epidemiology of psoriasis and palmoplantar pustulosis: a nationwide study using the Japanese national claims database.
BMJ Open 2015; 5: e006450,
I. Asian Pharmacoepidemiology Network (AsPEN)
18. Andersen M, Bergman U, Choi NK, Gerhard T, Huang C, Jalbert J, Kimura M, Kimura T,
Kubota K, Lai ECC, Ooba N, Ösby U, Park BJ, Pratt N, Roughead EE, Sato T, Setoguchi S,
Shin JY, Sundström A, Yang YHK.
The Asian Pharmacoepidemiology Network (AsPEN): Promoting multi-national collaboration for pharmacoepidemiologic research in Asia.
Pharmacoepidemiol Drug Saf. 2013; 22(7): 700-704,
19. Pratt N, Andersen M, Bergman U, Choi NK, Gerhard Y, Huang C, Kimura M, Kimura T,
Kubota K, Lai ECC, Ooba N, Ösby U, Park BJ, Sato T, Shin JY, Sundström A, Yang YHK, Roughead EE.
Multi-country rapid adverse drug event assessment: The Asian Pharmacoepidemiology Network (AsPEN)
antipsychoticand acute hyperglycaemia study.
Pharmacoepidemiol Drug Saf. 2013; 22(9): 915-924,
20. Pratt N, Chan EW, Choi NK, Kimura M, Kimura T, Kubota K, Lai EC, Man KK, Ooba N, Park BJ, Sato T,
Shin JY, Wong IC, Kao Yang YH, Roughead EE.
Prescription sequence symmetry analysis: assessing risk, temporality,
and consistency for adverse drug reactions across datasets in five countries.
Pharmacoepidemiol Drug Saf. 2015; 24(8): 858-864,
21. Roughead EE, Chan EW, Choi NK, Kimura M, Kimura T, Kubota K, Lai EC, Man KK, Nguyen TA, Ooba N,
Park BJ, Sato T, Shin JY, Wang T, Griffiths J, Wong IC, Yang YH, Pratt NL
Variation in Association Between Thiazolidinediones and Heart Failure Across Ethnic Groups:
Retrospective analysis of Large Healthcare Claims Databases in Six Countries.
Drug Saf. 2015; 38(9): 823-831,
22. Lai EC, Man KK, Chaiyakunapruk N, Cheng CL, Chien HC, Chui CS, Dilokthornsakul P, Hardy NC,
Hsieh CY, Hsu CY, Kubota K, Lin TC, Liu Y, Park BJ, Pratt N, Roughead EE, Shin JY,
Watcharathanakij S, Wen J, Wong IC, Yang YK, Zhang Y, Setoguchi S.
Brief Report: Databases in the Asia-Pacific Region: The Potential for a Distributed Network Approach.
Epidemiology 2015; 26(6): 815-820,
23. Lai ECC, Stang P, Yang YHK, Kubota K, Wong ICK, Setoguchi S.
International Multi-database Pharmacoepidemiology: Potentials and Pitfalls.
Curr Epidemiol Rep. 2015; 2: 229-238,
J. Pharmacoepidemiology study design
24. Kubota K.
Symmetry analysis for monitoring safety of newly marketed drugs.
Pharmacoepidemiol Drug Saf. 6 Oct 2015 [Epub ahead of print],